The clinical research and pharmaceutical industry continues to expand rapidly in India, creating strong demand for professionals skilled in Trial Master File (TMF) management and Veeva eTMF systems. Klinera is currently hiring experienced eTMF Specialists for its clinical operations and TMF management team.

This opportunity is ideal for candidates with experience in Veeva eTMF, TMF Reference Model, ALCOA+ principles, inspection readiness, and clinical trial documentation management. Professionals with backgrounds in pharmaceutical companies, biotechnology firms, and CROs are encouraged to apply.

Job Highlights

• Job Role: eTMF Specialist
• Company: Klinera
• Department: TMF / Clinical Operations
• Experience Required: 4+ Years
• Veeva eTMF Experience: Mandatory (3+ Years Preferred)
• Qualification: Bachelor’s Degree or Equivalent
• Industry: Pharmaceutical / Biotechnology / CRO
• Employment Type: Full-Time
• Application Mode: Email Application

eTMF Specialist Job Description

The eTMF Specialist will support the setup, maintenance, quality review, and archival of Trial Master Files (TMF) throughout the clinical trial lifecycle. The role focuses on ensuring TMF inspection readiness, regulatory compliance, and document quality in accordance with ICH-GCP guidelines and sponsor requirements.

Candidates with strong knowledge of TMF management, Good Documentation Practices (GDP), ALCOA++ principles, and Veeva Systems eTMF will be preferred.

Key Responsibilities of eTMF Specialist

TMF Management Activities

• Support TMF setup, maintenance, and closeout activities
• Ensure Trial Master File completeness and inspection readiness
• Manage document filing and reconciliation activities

Quality Control & Compliance

• Perform ALCOA+ Quality Check (QC) reviews of TMF documents
• Conduct Completeness Reviews against Expected Document Lists
• Identify and resolve TMF Quality Issues (QIs)
• Ensure compliance with global regulatory standards and sponsor requirements

Clinical Trial Documentation Support

• Facilitate interim TMF reviews and follow-up actions
• Generate TMF health metrics and compliance reports
• Support inspection readiness initiatives
• Coordinate with cross-functional clinical development teams

Required Qualifications

Candidates applying for this eTMF Specialist job should meet the following criteria:

• Bachelor’s Degree or equivalent qualification
• Minimum 4+ years of TMF or records management experience
• Experience working in pharmaceutical, biotechnology, or CRO organizations
• Strong understanding of:
  • TMF Reference Model
  • ALCOA++ principles
  • Good Documentation Practices (GDP)
  • ICH-GCP guidelines
• Minimum 3+ years of Veeva eTMF experience
• Knowledge of clinical trial planning and execution
• Ability to manage multiple deliverables within timelines
• Strong stakeholder communication skills

Preferred Skills

• Expertise in Veeva Systems eTMF
• Strong TMF Quality Review experience
• Clinical documentation management skills
• Regulatory compliance understanding
• Inspection readiness experience
• Problem-solving and issue resolution capabilities

Why Apply for This eTMF Specialist Role?

The demand for skilled TMF professionals is increasing across the clinical research industry due to stricter regulatory expectations and digitized clinical trial operations. This role offers an opportunity to work on global clinical trials while gaining exposure to:

• Advanced Veeva eTMF systems
• Inspection readiness projects
• Global clinical documentation standards
• Cross-functional clinical development operations
• Regulatory compliance management

Professionals with expertise in clinical trial documentation, TMF quality control, Veeva eTMF, and ALCOA+ compliance can significantly enhance their career growth through this opportunity.

Salary Expectations

Based on current industry standards for experienced eTMF professionals in India, the expected salary range for this role may vary between:

• ₹6 LPA – ₹12 LPA (Approximate)

Salary may depend on:

• Total TMF experience
• Veeva eTMF expertise
• CRO/pharmaceutical background
• Inspection readiness experience

How to Apply

Interested candidates can share their updated resume via email in the following format:

• Current CTC
• Expected CTC
• Notice Period (NP)
• Experience in Veeva – Yes/No
• Experience in ALCOA – Yes/No

Apply via Email:

To: prachi.sonawane@klinera.com

Current CTC –
Expected CTC –
Notice Period –
Experience in Veeva – Yes/No
Experience in ALCOA – Yes/No

Please find my updated resume attached for the eTMF Specialist position.